Hearing loss, which may be due to many different causes, is generally of two types, conductive and sensorineural. Of these types, conductive hearing loss occurs where the normal mechanical pathways for sound to reach the hair cells in the cochlea are impeded, for example, by damage to the ossicles. Conductive hearing loss may often be helped by use of conventional hearing aid systems, which comprise a microphone and an amplifier for amplifying detected sounds so that acoustic information does reach the cochlea and the hair cells.
In many people who are profoundly deaf, the reason for deafness is sensorineural hearing loss, which is caused by an absence of, or destruction of, the hair cells in the cochlea which transduce acoustic signals into nerve impulses. These people are thus unable to derive suitable benefit from conventional hearing aid systems, no matter how loud the acoustic stimulus is made, because there is damage to or absence of the mechanism for nerve impulses to be generated from sound in the normal manner. It is for this purpose that cochlear implant systems have been developed. Such systems bypass the hair cells in the cochlea and directly deliver electrical stimulation to the auditory nerve fibres, thereby allowing the brain to perceive a hearing sensation resembling the natural hearing sensation normally delivered to the auditory nerve. U.S. Pat. No. 4,532,930, the contents of which are incorporated herein by reference, provides a description of one type of traditional cochlear implant system.
Cochlear implant systems have typically consisted of two essential components, an external component commonly referred to as a processor unit and an internal implanted component commonly referred to as a stimulator/receiver unit. Traditionally, both of these components have cooperated together to provide the sound sensation to a user.
The external component has traditionally consisted of a microphone for detecting sounds, such as speech and environmental sounds, a speech processor that converts the detected sounds, particularly speech, into a coded signal, a power source such as a battery, and an external transmitter coil.
The coded signal output by the speech processor is transmitted transcutaneously to the implanted stimulator/receiver unit situated within a recess of the temporal bone of the user. This transcutaneous transmission occurs via the external transmitter coil which is positioned to communicate with an implanted receiver coil provided with the stimulator/receiver unit. This communication serves two essential purposes, firstly to transcutaneously transmit the coded sound signal and secondly to provide power to the implanted stimulator/receiver unit. Conventionally, this link has been in the form of an RF link, but other such links have been proposed and implemented with varying degrees of success.
The implanted stimulator/receiver unit traditionally includes a receiver coil that receives the coded signal and power from the external processor component, and a stimulator that processes the coded signal and outputs a stimulation signal to an intracochlea electrode assembly which applies the electrical stimulation directly to the auditory nerve producing a hearing sensation corresponding to the original detected sound.
As the implant is surgically implanted within the recipient, there is a need to obtain data about the actual performance of the electrode array following implantation go as well as the response of the auditory nerve to stimulation. Such data collection enables detection and confirmation of the normal operation of the device, and allows the stimulation parameters to be optimised to suit the needs of the patient.
Typically, following the surgical implantation of the cochlear implant, the recipient must have the implant fitted or customised to conform with the specific recipient demands. This procedure collects and determines patient specific parameters such as threshold levels (T levels) and maximum comfort levels (C levels) for each stimulation channel. Essentially, this is manually performed by applying stimulation pulses for each channel and receiving an indication from the implant recipient as to the level and comfort of the resulting sound. For implants with a large number of channels for stimulation, this process is quite time consuming and rather subjective as it relies heavily on the recipient's subjective impression of the stimulation rather than any specific measurement. This aspect is further complicated in the case of children and prelingually or congenitally deaf patients who are unable to supply an accurate impression of the resultant hearing sensation, and hence fitting of the implant may be sub-optimal. In such cases an incorrectly fitted implant may result in the recipient not receiving optimum benefit from the implant and in the cases of children may directly hamper the speech and hearing development of the child.
Therefore, as previously mentioned, there is a need to obtain objective measurements of patient specific data especially in cases where an accurate subjective measurement is not possible.
One proposed method of interrogating the performance of the implanted device and making objective measurements of patient specific data such as T and C levels is to directly measure the response of the auditory nerve to an electrical stimulus. The measurement of Electrically Evoked Compound Action Potentials (ECAPs) provides an objective measurement of the response of the nerves to electrical stimulus. Following electrical stimulation, the neural response is caused by the superposition of single neural responses at the outside of the axon membranes. The ECAP can then be measured in response to various stimulations and from this the performance of the implant can be assessed and patient parameters can be interpolated.
Indeed, there is a need to measure the response of nerves to electrical stimulation in many applications, and not just in the area of cochlear implants. The measurement of ECAPs has proven to provide a useful objective measurement in many such applications. By measuring the ECAP in response to a stimulation, the effectiveness of the stimulation can be assessed in relation to the neural response evoked by the stimulation.
A number of ECAP measurement methods and devices have been developed which attempt to measure the response of the nerves to electrical stimulus. In the area of cochlear implants where electrical stimulus is delivered to the nerve cells within the cochlea, such systems have essentially attempted to use the electrodes implanted within the cochlea to both deliver stimulation and to detect the responses of the nerves to such stimulation.
U.S. Pat. No. 5,758,651 describes one system and apparatus for recovering ECAP data from a cochlear implant. This system measures the neural response to the electrical stimulation by using the stimulus array to not only apply the stimulation but to also detect and receive the response. In this system the array used to stimulate and collect information is a standard intra-cochlear and/or extra-cochlear electrode array. Following the delivery of a stimulation pulse via chosen stimulus electrodes, all electrodes of the array are open circuited for a period of time prior to and during measurement of the induced neural response. The purpose of open circuiting all electrodes during this period is to reduce the detected stimulus artefact measured with the ECAP nerve response.
Whilst prior art systems of this type have proven useful in capturing and investigating evoked neural responses in the cochlea, there are still a number of intrinsic limitations associated with such systems, which have affected the quality of the measurements of the neural response. In the main this has been due to the presence of stimulus artefacts in the measurement detected, resulting in a measurement being taken which is not necessarily a true indication of the actual ECAP response present.
The process of distinguishing the actual ECAP from stimulus artefacts has presented considerable difficulties, including problems such as the fact that the signals that are to be measured are extremely low level signals (down to the order of 10 uV). In cochlear implant applications in particular, an intracochlear electrode usually delivers a stimulus pulse with an amplitude typically in the range of 1V to 10V, which is many orders of magnitude greater than the ECAP response that is to be measured resulting from this stimulation.
Providing for a system that is firstly able to deliver a stimulus of sufficient amplitude and also to detect the elicited response of the nerves to that particular stimulation has therefore been problematic. Due to the nature of the neural response, the sensing system must be ready to record this response within a short delay (preferably less than 50 us) after completion of the stimulus. In order to properly resolve the very small neural signal a large amplifier gain is required (typically of about 60 dB to 70 dB), however the neural signal is often superimposed on a much larger artefact which makes it difficult to extract the neural signal of interest due to the finite dynamic range of the amplifier and the need for high gain to resolve the signal.
In the past, the only way useful measurements have been able to be obtained from the associated artefacts has been through the use of extensive post processing techniques. These techniques have attempted to apply complicated mathematical algorithms to the associated measurements in an attempt to cancel out the presence of the artefacts in the measurements. Such a system does not provide immediate results which can be acted upon, as the measured results often require time consuming analysis before they can be used. With the need to use such results immediately to adjust patient T and C levels, existing methods are not satisfactory.
Similar needs exist in respect of measurement of neural responses evoked by other types of devices.
Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention before the priority date of each claim of this application.